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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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Stroke is the fifth leading cause of death in the United States and is the leading cause of long term disability. Distinct geographic disparities in stroke mortality, with highest rates in the southeast United States including Arkansas, are known as the "stroke belt." There the average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the leading cause of serious long-term disability. Between 2012 and 2030, disability and medical costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with the majority of the projected increase in costs arising from those 65 to 79 years of age.
There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in 85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond the effective time window for therapy is a common reason for failure.
To reduce the devastating impact of stroke on individuals and society, the investigators continue to seek ways to improve functional recovery and limit ischemic damage in stroke patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has recently shown strong positive effects in pre-clinical animal models of acute ischemic stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants and blood substitutes yet none have been successful.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.05 mL/kg DDFPe | Active Comparator | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
|
| 0.05 mL/kg Placebo | Placebo Comparator | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
|
| 0.10 mL/kg DDFPe | Active Comparator | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
|
| 0.10 mL/kg Placebo | Placebo Comparator | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05 mL/kg DDFPe | Drug | Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities | The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol. If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop. | 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS) |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS Assessment | The NIH Stroke Scale (NIHSS) is an assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination. Ratings for each item are scored on a 3- to 5-point scale with 0 as normal. Scores range from 0 to 42, with higher scores indicating greater severity. | NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge. |
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Inclusion Criteria:
Exclusion Criteria:
Currently pregnant or breastfeeding
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| Name | Affiliation | Role |
|---|---|---|
| William Culp, MD | University of Arkansas | Principal Investigator |
| Sanjeeva Onteddu, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31349978 | Result | Culp WC, Onteddu SS, Brown A, Nalleballe K, Sharma R, Skinner RD, Witt T, Roberson PK, Marsh JD. Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial. J Vasc Interv Radiol. 2019 Aug;30(8):1244-1250.e1. doi: 10.1016/j.jvir.2019.04.020. |
| Label | URL |
|---|---|
| Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial | View source |
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During the study period, 26 patients or their legal authorized representatives were contacted and agreed to participate. Of these, 24 give written informed consent and were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.05 mL/kg DDFPe | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.05 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg). |
| FG001 | 0.05 mL/kg Placebo | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.05 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg). |
| FG002 | 0.10 mL/kg DDFPe | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.10 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg). |
| FG003 | 0.10 mL/kg Placebo | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.10 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg). |
| FG004 | 0.17 mL/kg DDFPe | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.17 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg). |
| FG005 | 0.17 mL/kg Placebo | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.17 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study.
For this reason, all control subjects are grouped.
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| ID | Title | Description |
|---|---|---|
| BG000 | Controls (n=6) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. For analysis, all control subjects are grouped. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities | The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol. If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop. | No signs of dose-limiting episodes were identified at any dose level, and no MTD was defined. | Posted | Number | Dose Limiting Toxicities | 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS) |
|
The study treatment follow-up was within 90 days following the last administration of study treatment.
At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study.
For this reason, all control subjects are grouped.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controls (n=6) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. For this reason, all control subjects are grouped. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusional State | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
Limitations of the current study primarily concern the exploratory aim toward efficacy, which was greatly underpowered for any purpose other than designing the next study. As with any phase I trial, the small number of cases may only demonstrate side effects and complications that are common.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Unger, MD | NuvOx Pharma | 520-624-6688 | eunger@nuvoxpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2018 | Apr 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 0.17 mL/kg DDFPe | Active Comparator | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
|
| 0.17 mL/kg Placebo | Placebo Comparator | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
|
|
|
| 0.05 mL/kg Placebo | Drug | Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg). |
|
| 0.10 mL/kg DDFPe | Drug | Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg). |
|
|
| 0.10 mL/kg Placebo | Drug | Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg). |
|
| 0.17 mL/kg DDFPe | Drug | Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg). |
|
|
| 0.17 mL/kg Placebo | Drug | Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg). |
|
| Modified Rankin Scale (mRS) | The modified Rankin Scale is a measure of the degree of disability in patients who have had a stroke with 0 being no symptoms at all to 6 being death. Thus, a higher score indicates greater severity. | mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90. |
| BG001 |
| DDFPe - 0.05 mL/kg (n=6) |
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| BG002 | DDFPe - 0.10 mL/kg (n=6) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| BG003 | DDFPe - 0.17 mL/kg (n=6) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| NIHSS Assessment | The NIH Stroke Scale (NIHSS) is an assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination. Ratings for each item are scored on a 3- to 5-point scale with 0 as normal. Scores range from 0 to 42, with higher scores indicating greater severity. | Median | Full Range | units on a scale |
|
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| OG001 | 0.05 mL/kg Placebo | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| OG002 | 0.10 mL/kg DDFPe | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| OG003 | 0.10 mL/kg Placebo | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| OG004 | 0.17 mL/kg DDFPe | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
| OG005 | 0.17 mL/kg Placebo | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. |
|
|
| Secondary | NIHSS Assessment | The NIH Stroke Scale (NIHSS) is an assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination. Ratings for each item are scored on a 3- to 5-point scale with 0 as normal. Scores range from 0 to 42, with higher scores indicating greater severity. | At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. All control subjects are grouped for the NIHSS results. DDFPe results are shown separately for each cohort as well as combined. | Posted | Median | Full Range | units on a scale | NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge. |
|
|
|
| Secondary | Modified Rankin Scale (mRS) | The modified Rankin Scale is a measure of the degree of disability in patients who have had a stroke with 0 being no symptoms at all to 6 being death. Thus, a higher score indicates greater severity. | At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. All control subjects are grouped for the mRS results. DDFPe results are shown separately for each cohort as well as combined. | Posted | Median | Full Range | units on a scale | mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90. |
|
|
|
| 1 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | DDFPe - 0.05 mL/kg (n=6) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. | 1 | 6 | 1 | 6 | 6 | 6 |
| EG002 | DDFPe - 0.10 mL/kg (n=6) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | DDFPe - 0.17 mL/kg | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | DDFPe Total (n=18) | This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. | 1 | 18 | 1 | 18 | 15 | 18 |
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Cardiac Pacemaker Replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cerebrovascular Accident, Secondary Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Arrythmia | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | Non-systematic Assessment |
|
| Electrocardiogram Abnormal | Cardiac disorders | Non-systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infusion Related Reaction | General disorders | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Vascular device occlusion | General disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Carotid Endarterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Haemorrhoids | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 2 hours |
|
| 3.5 hours |
|
| 7.5 hours |
|
| Day 7 or Day of Discharge |
|
| 30 day |
|
| 90 day |
|